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Thermo Fisher Scientific

The World Leader In Serving Science

Contract Specialist

Billing SpecialistBilling SpecialistFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Germany

Posted

92 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Contract Specialist

Thermo Fisher Scientific

Title: FSP_Germany_Contract Specialist Location: Remote Germany Ful ltime As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts. What You’ll Do: • Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process. • Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. • Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations. • Ensures compliance of budgetary guidance, templates and process. • Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes. • Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels. • Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation. • Achieve target cycle times for site activations. • Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws • Demonstrated ability to apply basic principles of investigator grant negotiation • General understanding of business and financial principles that related to service agreements • Effective communication skills (verbal & written) in English and local language • Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters • Demonstrated ability in attention to detail • Excellent analytical and decision based thinking skills • Understanding of the pharmaceutical product development process and involvement of CROs • Able to work independently or in a team environment • Good organizational and time management skills • Working knowledge of PPD SOP & WPDs • Able to organize competing priorities logically and review outstanding contractual risk and issues • Able to effectively use automated systems and computerized applications • Ability to demonstrate a customer focused style of communication, problem solving and collaboration

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Country Approval Specialist

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The World Leader In Serving Science

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Title: Country Approval Specailist FSP - Italy, France & Spain Location: Remote Milano Italy, Spain, France Full time As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. What You’ll Do: • Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. • Provides project specific local SIA services and coordination of these projects. • May have contact with investigators for submission related activities. • Key-contact at country level for either Ethical or Regulatory submission-related activities. • Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieves PPD’s target cycle times for site. • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • May develop country specific Patient Information Sheet/Informed Consent form documents. • May assist with grant budgets(s) and payment schedules negotiations with sites. • Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. • Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. • Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

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Benefits Enrollment Specialist

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Thermo Fisher Scientific logo

Contract Specialist

Thermo Fisher Scientific

The World Leader In Serving Science

Full TimeRemoteTeam 10,001+Since 1956H1B Sponsor

Title: Contract Specialist - FSP Dedicated - France, Spain & Italy Location: Remote France, Spain, Italy Full time Our team is expanding, and we are looking to recruit a Contract Specialist or Senior Contract Specialist for our growing FSP environment. - The Contract Specialist in the FSP group is responsible for managing and overseeing contractual aspects of clinical trials conducted by the FSP on behalf of its clients. This role involves negotiating, drafting, and finalizing high-value and complex contracts, ensuring compliance with relevant regulations, and maintaining effective communication with internal and external stakeholders. The Senior Contract Specialist also provides mentorship and guidance to junior contract specialists.   Key Responsibilities: - Draft, review, and negotiate high-value and complex contracts related to clinical trials, including Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), and other relevant documents. - Ensure contracts are compliant with local and international regulations and company policies. - Collaborate with internal teams, including legal, clinical operations, regulatory affairs, and finance, to ensure alignment and compliance with contractual requirements. - Liaise with external stakeholders, including clients, sites, and vendors, to facilitate the contract negotiation and approval process. - Monitor the progress of contract negotiations and address any issues or concerns that arise. - Maintain accurate records and documentation related to contracts and agreements. - Provide guidance and support to project teams on contractual matters throughout the lifecycle of clinical trials. - Participate in the development and implementation of contract management strategies and processes. - Ensure timely execution of contracts to meet project timelines and deadlines. - Support the resolution of contractual disputes and issues as they arise. - Stay up-to-date with changes in regulations and industry standards related to clinical trial contracts. - Mentor and provide guidance to junior contract specialists, assisting in their professional development. - Participate in training sessions and workshops to enhance the contract management skills of the team.   Qualifications: - Bachelor’s degree in a relevant field (e.g., Law, Business Administration, Life Sciences). - Extensive experience in contract management or negotiation within the pharmaceutical, clinical research, or related industry. - Strong knowledge of contractual regulations and guidelines governing clinical trials. - Excellent organizational and project management skills. - Effective communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams. - Attention to detail and the ability to manage multiple projects and deadlines. - Proficiency in both written and spoken English; additional language skills may be beneficial depending on the location.   Preferred Qualifications: - Advanced degree or certification in contract management or a related field. - Experience in an FSP environment, providing services to multiple clients. - Familiarity with electronic contract management systems and databases. - Previous experience in a senior or leadership role within contract management.

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Role Description The Coding Specialist is responsible for reviewing documents to identify all procedures and diagnoses. The Coding Specialist must ensure the encounters have been coded correctly based on documents received and using the most current coding guidelines. The Coding Specialist should be able to communicate and recognize inadequate or incorrect documentation so that all coding is completed compliantly. - Performs ongoing analysis of medical record documentation and codes assigned per CMS, CPT, and Ventra Health documentation guidelines. - Assign appropriate ICD-10-CM and CPT codes and modifiers according to documentation. - Perform MIPS review as needed. - Perform Provider QA as needed. - Document coding errors. - Assist coding management. - Assist with client/provider audits as needed. - Assist with reviewing work product of new coders in training, as needed. - Provides feedback to coders on coding discrepancies/deficiencies, as needed. - Provides feedback to coding manager on documentation deficiencies in a timely manner. - Respond to questions from designated coders. - Maintain confidentiality for all personal, financial, and medical information found in medical records per HIPAA guidelines and Ventra Health policy. Qualifications - High School diploma or equivalent. - RHIT and/or CPC required. - At least one (1) year of medical billing preferred. - 2023 MDM Guidelines required. Requirements - Understand the use and function of modifiers in CPT. - In-depth knowledge of CPT/ICD-10 coding system. - Ability to read and interpret documentation and assign appropriate codes for diagnosis and procedures. - Ability to read, understand, and apply state/federal laws, regulations, and policies. - Ability to remain flexible and work within a collaborative and fast-paced environment. - Ability to communicate with diverse personalities in a tactful, mature, and professional manner. - Knowledge of the requirements of medical record documentation. - Knowledge of medical terminology and anatomy. - Strong oral, written, and interpersonal communication skills. - Strong time management and organizational skills. - Basic use of computer, telephone, internet, copier, fax, and scanner. - Basic knowledge of Outlook, Word, and Excel. - Become proficient in the use of billing software within 4 weeks and maintain proficiency. - Understand and comply with company policies and procedures. Benefits - 100% remote in South India – Andhra Pradesh, Tamil Nadu, Telangana, Kerala, & Karnataka. - Full-time opportunity. - Competitive salaries plus incentive in INR. - Day shift hours, 5-day (M-F) work schedule, & collaborative team culture. - Day 1 - 3 orientation onsite and equipment pickup in Chennai Service Delivery. - Day 4 training will begin remotely (WFH). - We offer the following benefits – PF, Gratuity, ESI or Group Insurance. - Colleague Recognition Programs – Monthly VIP, Spot Recognition, & IJP Career Progression.

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